US cell-based flu vaccine plant open for business

flu240Americans may soon be getting flu jabs made with cells and not eggs. The drug company Novartis opened a first-of-its kind facility in the US to produce influenza vaccines using mammalian cells, Novartis and US government officials announced 13 December.

The approach is an alternative to conventional vaccine manufacturing, which relies on culturing stocks inside chicken eggs. That method is cheap and fairly reliable, but quite slow.

Producers must order specially bred eggs months in advance, and the viruses that compose the vaccine must be first adapted to grow in eggs. This delay means that the vaccine strain produced can be an imperfect match to influenza strains in circulation, and it also stymies a quick response to influenza pandemics. Egg proteins can also cause an allergic reaction, and contamination problems have led to vaccine shortages in the past.

Vaccines grown in mammalian cells are likelier to be more reliable and quicker to produce. The Novartis facility, based in Holly Springs, North Carolina, has already created lots of “pre-pandemic” H5N1 vaccines for a national stockpile, according to CIDRAP. The company says the facility could produce a quarter of the vaccines needed for the US in case of an influenza pandemic.

It first must win approval from the US Food and Drug Administration. A late stage clinical trial published last year showed that the vaccine was just as effective as an egg-based vaccine (see Cell-based flu vaccines ready for US prime time), and cell-based vaccines are approved for sale in Europe (see Production technologies change flu vaccine landscape). Another vaccine maker, Baxter, is also seeking approval to distribute a cell-based flu vaccine in the US.

The US Department of Health and Human Service supported development of the Novartis facility with contracts worth $220 million and $487 million.

Image courtesy Wikimedia Commons

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